Appeals Court Revives Decongestant Lawsuit Against Big Pharma

A federal appeals court has revived portions of a nationwide litigation against drugmakers and retailers over decongestants that allegedly don't work. The lawsuits, filed after a FDA advisory panel found oral phenylephrine to be no better than a placebo, initially dismissed by a US District Judge in Brooklyn.

The 2nd U.S. Circuit Court of Appeals said the Federal Food, Drug and Cosmetic Act preempted most state law-based claims against defendants like Procter & Gamble and CVS, as they followed FDA labeling requirements. However, it revived claims over 'maximum strength' decongestants, which some defendants added on their own.

The court also reinstated claims over brand-name drugs approved through the federal New Drug Application process, allowing defendants to update labels with new science. Despite this decision, consumers lack standing to pursue a civil racketeering claim accusing defendants of defrauding the public and the FDA.